Aug 18, 2011

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding post-market surveillance requirements for pediatric products.

 The guidance stems from changes made to Section 522 of the FDA Amendments Act of 2007 that authorize the FDA to order postmarket surveillance periods of longer than 36 months for Class II and III devices with significant pediatric applications; 510(k) clearance or PMA approval of those devices would be contingent upon meeting those postmarket surveillance requirements.

The FDA emphasizes that section 522 postmarket surveillance requirements apply not only to devices labeled for pediatric use, but also devices with off-label pediatric applications. The agency may order postmarket surveillance studies of durations longer than 36 months in instances where a device’s impact on growth and development needs to be assessed.

The FDA’s Center for Devices and Radiological Health (CDRH) has the authority to require postmarket surveillance studies at any point in a device’s lifecycle. The guidance lists several examples of when in the pre- or post-market process the CDRH may order surveillance:

  • To confirm the nature, severity or frequency of issues contained in adverse event reports or published literature
  • To gain more experience with a change in the device’s use from hospital to home settings, or with new patient populations
  • To address long-term or infrequent safety and effectiveness questions regarding implantable devices and other products that premarket testing does not adequately cover
  • To better define a device’s problems stemming from unexpected adverse events after that device’s marketing has begun

In the event that the CDRH orders a manufacturer to conduct a postmarket surveillance study, the guidance lists key elements to include in a study plan, including device description and indications for use, study purpose and objectives, design, and timelines. Guidelines for submitting interim and final study reports, as well as content and formatting requirements, are also covered.


  • Stewart Eisenhart